Sunday, September 25, 2005

Weeds break through the surface

As a strange follow-up to my blog of September 16 about the resignation of Dr. Susan F. Wood as the director of the FDA's Office of Women's Health, Lester M. Crawford, FDA Commissioner resigned suddenly on Friday (although this news is not posted on the FDA website as of today, Saturday, September 24, 2005). Apparently this resignation, only two months after his confirmation, had nothing to do with the Plan B stonewalling, which, after all, was what the administration wanted, and everything to do with financial improprieties Crawford had not disclosed to the Senate during his confirmation hearings. The FDA has been severely criticized in recent years for putting politics before science, and for shielding drug companies by withholding information from the public.

FYI, the postponement of the emergency contraception decision was the subject of a recent New England Journal of Medicine commentary, "A Sad Day for Science at the F.D.A."

Meanwhile, as a sequel to drug companies influencing physician prescription practices, we have this week a report by Reed Abelson of the New York Times on device manufacturers who have consulting contracts with doctors who use their products. (See related editorial in the Saturday, September 24, New York Times and report by CNN News.) So now that there is public disclosure, by the media, if not by medicine, of the ways many doctors are influenced to make treatment decisions based on their financial interest instead of on the best interest of the patient, what are patients to do? The Times editorial suggests that full disclosure by doctors to their patients would be a good start, “That would alert patients and institutions to look hard at whether the devices recommended by a doctor-consultant were really the best to use.” But realistically, should patients be expected to do their own research (even if sources were available), on which drugs or devices are best? Surely we can agree that professional ethics requires not only disclosure, but complete separation of practice decisions about drugs and devices from financial self-interest.

For a really good review of evidence and issues related to physician ties with pharma, read this piece by Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine. (“Physicians' Ties With The Pharmaceutical Industry: A Critical Element Of A Wildly Successful Marketing Network,”) Kassirer hits hardest at the medical elite, those academic physicians who should be professional leaders, who should set ethical standards, who are the educators of the next generations of physicians.

[W]e should not lose sight of the fact that patients do not order the industry’s products, physicians do. And physicians represent the audience for the pharmaceutical industry’s marketing efforts. The physician network that the pharmaceutical industry has engaged in these marketing efforts is truly impressive. With minor exceptions, most of academic medicine seems to be involved in one way or another in industry’s marketing efforts: carrying out research that shed a good light on a drug, testifying about a drug’s good qualities, writing papers and pamphlets and developing clinical practice guidelines and registries that that promote products, working behind the scenes to help avoid litigation. And all the time, in the pay of industry. It is an impressive network of people who have been assembled either intentionally or inadvertently by industry to do its bidding. Because the doctors order the drugs, the companies depend on their passive acquiescence or active participation in their marketing efforts. Many physicians are not just being compliant, but also complicit.

Kassirer ends with this admonition: “'Conflicts of interest are institutional weeds. They take root below the surface and become pervasive problems often long before they show their ugliness.'” Unfortunately, the weeds have long since broken through the surface."

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